BEC - Key Persons

Job Titles:

• Consultant Within the FDA

Frances Cartagena is a consultant within the FDA-regulated industries with over 20 years of experience in operations and quality; managing areas such as Operational Excellence and CAPA. She has a bachelor degree in Chemistry from Interamerican University of Puerto Rico. She also has a master degree in Business Administration from University of Phoenix with a major in Technology Management. Her work covers training in root cause and effective CAPA, and Human Error workshops. She has working experience in consent decrees. She is an ASQ Certified Six Sigma Green Belt and Certified Quality Auditor, and ISO 13485:2003 Certified Lead Auditor, and part of BEC Inc. since 2013.

Job Titles:

• Founder
• President

José (Pepe) Rodríguez-Pérez, President and founder holds a bachelor's degree in biology and a PhD in immunology, both from the University of Granada, Spain, with post-graduate studies in medical sciences. During his 25+ year of career, he spent over 15 years working in a manufacturing plant (Abbott Laboratories). He also was a Science Advisor for the U.S. FDA from 2009 to 2012. He founded Business Excellence Consulting in May 2005 and since then has been leading its operation and expansion to a global consulting firm. He served as a senior member of the American Society of Quality and Chair of the Puerto Rico section during the period 2003-05. He was secretary from 2005 to 2012. Pepe holds seven American Society of Quality (ASQ) certifications: Certified Six Sigma Black Belt, Manager of Quality & Organizational Excellence, Quality Engineer, Quality Auditor, HACCP Auditor, Pharmaceutical GMP Professional, and Biomedical Auditor. He is also a member of RAPS, ISPE, AAMI, and PDA. He is the author of five best-selling books (published by ASQ-Quality Press) covering FDA topics: CA PA for the FDA - Regulated Industry (2010), Quality Risk Management in the FDA-Regulated Industry (2012), The FDA & Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals (2014), the Handbook of Investigation and Effective CAPA Systems (2016), and Quality Risk Management in the FDA-Regulated Industry 2nd edition (2017). He is also author of several peer-review articles covering topics such as risk management, CAPA system, and data integrity.

Job Titles:

• Management System Implementation and Training Consultant

Leslie Orama is a management system implementation and training consultant within the FDA-regulated industries with over 22 years of experience. She has a bachelor degree in Chemistry from the University of Puerto Rico. She also has a master degree in Environmental Planning from Metropolitan University, Puerto Rico. Since year 2017, she is fully devoted to consulting under BEC Inc, focusing on training of food, internal audit, quality system regulations, root cause and effective CAPA, and management systems implementation. She is a Certified Planner, ISO 9001 and ISO 22000 Lead Assessor.

Madeline Muñoz has over 20 years of experience in the pharmaceutical industry. She has held leading positions as Production Manager, QA Director and Quality Systems Director for a major pharmaceutical company. Her areas of expertise are warning letter remediation, complaint and manufacturing investigations, CAPA, change control, product disposition, gap assessments and FDA PAI readiness. Mrs. Muñoz has worked as a consultant, leading international projects helping clients pass FDA inspections with zero observations. She is an ISO 13485:2003 Lead Auditor and has been part of BEC Inc. since 2012.

Job Titles:

• Process Improvement and Training Consultant

Manuel E. Peña-Rodríguez is a process improvement and training consultant with more than 20 years of experience. He also serves as professor in the graduate program in biochemistry at the University of Puerto Rico, Medical Sciences Campus, in San Juan. Manuel is a licensed Professional Engineer with a master degree in Engineering Management from Cornell University, and a J.D. He is an ASQ Certified Six Sigma Black Belt, Manager of Quality & Organizational Excellence, Quality Engineer, Quality Auditor and Biomedical Auditor, and an ISO 13485:2003 lead auditor. Also a senior member of ASQ and former Chair of the Puerto Rico section. He is the author of the book "Statistical Process Control for the FDA-Regulated Industry", published by ASQ Quality Press in April 2013 and author of several peer-review articles covering topics such as risk management and sampling. He has been part of BEC Inc. since 2006.

Job Titles:

• Vice - President and Co - Owner of BEC Inc.

Norma L. Copeland, Vice-President and co-owner of BEC Inc. She has a bachelor's degree in business administration, major in accounting from the University of Puerto Rico. Prior of founding BEC Inc. she worked in the advertisement industry. She oversees human resources and all administrative aspects of the company.